FDA (Devices) recall action 94570
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Complaints of unexpected detachment of the collimator have been reported.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Mirion Technologies is recalling the Captus 4000e Thyroid Uptake System due to complaints of unexpected collimator detachment. Affected users should contact the manufacturer for guidance.
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.
Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.